In the three
months since I was sworn in as Inspector General of the Department of Health
and Human Services (HHS), I have seen firsthand the importance of the work
done by the Office of Inspector General (OIG) in ensuring the integrity of
our Federal health care programs. As the HHS Inspector General, I have become
aware of ways in which existing OIG policies can be modified to better serve
both providers and those charged with protecting the Federal health care programs.
For these reasons, I am pleased to announce modifications to OIG policies
and practices that are responsive to concerns that we have heard from the
provider and enforcement community regarding the civil settlement process.

In an effort
to improve the corporate integrity agreement and voluntary compliance initiatives,
our office has been engaged in an ongoing dialogue with the provider community.
For example, we recently completed a survey of providers and held a roundtable
discussion with compliance officers from providers operating under corporate
integrity agreements. With the help of the provider community, the OIG has
been working to promote the adoption of voluntary compliance programs, including
issuing compliance program guidances, special fraud alerts, and advisory opinions.
The OIG will continue to be a leader in promoting voluntary compliance.

As a result
of the OIG's outreach efforts, we recognize the provider community's interest
in streamlining the civil recoveries process. The OIG and the Department of
Justice will continue to seek to resolve a provider's permissive exclusion
liability concurrently with its False Claim Act liability. However, we recognize
there may be a limited number of cases where it would be appropriate to resolve
a provider's permissive exclusion liability separately or subsequent to resolution
of the False Claims Act case. We also recognize that in certain cases it may
be appropriate to release the OIG's administrative exclusion authorities without
a corporate integrity agreement. I have directed my staff to consider the
following criteria when determining whether to require a corporate integrity
agreement, and, if so, the substance of that agreement: (1) whether the provider
self-disclosed the alleged misconduct; (2) the monetary damage to the Federal
health care programs; (3) whether the case involves successor liability; (4)
whether the provider is still participating in the Federal health care programs
or in the line of business that gave rise to the fraudulent conduct; (5) whether
the alleged conduct is capable of repetition; (6) the age of the conduct;
(7) whether the provider has an effective compliance program and would agree
to limited compliance or integrity measures and would annually certify such
compliance to the OIG; and (8) other circumstances, as appropriate.

Through our
communications with providers, we have also become aware of and are concerned
about the financial impact of corporate integrity agreements on providers.
To address this concern, the OIG is modifying the provisions of our corporate
integrity agreements that address billing reviews and the use of independent
review organizations to reduce their financial impact, without weakening the
integrity of a provider's compliance program. Specifically, the corporate
integrity agreement billing review requirements will, in the future, require
the use of a full statistically valid random sample only in instances where
the initial claims review (which we will call a discovery sample) identifies
an unacceptably high error rate. (1) This modification,
once finalized, will be incorporated into future corporate integrity agreements,
and, where appropriate, will be made available to providers currently operating
under a corporate integrity agreement. We will also be exploring ways to increase
reliance on providers' internal audit capabilities, and offer additional flexibility
in other corporate integrity agreement requirements, such as employee training.

The OIG will
be reviewing each provider's corporate integrity agreement to determine whether
it is appropriate to incorporate the new claims review procedures into the
provider's existing corporate integrity agreement. Our office will contact
providers regarding amendments to existing corporate integrity agreements.
A further explanation of this amendment process is more fully set forth in
a series of frequently asked questions, which will be posted on the OIG's
website at http://oig.hhs.gov
or from the OIG's Public Affairs office at 202/619-1343.

In conclusion,
I think you will see many positive changes in the way the OIG approaches its
civil enforcement initiatives and corporate integrity agreements. We will
continue to balance our enforcement initiatives with provider outreach and
education in order to ensure the integrity of our Federal health care programs.